Table 4.
HRCT scan | An HRCT Emphysema Score of 4-4-4 in the right lung or 4-4 in the left lung. Evidence of large bullae (encompassing >30% of either lung) in a non-target lobe. |
Pulmonary function | FEV1 < 15% predicted value. DLco < 20% predicted value. Clinically significant bronchiectasis. Pulmonary nodule requiring surgery. History of recurrent respiratory infections (>1 hospitalization in the last year). Clinically significant (> 4 tablespoons per day) sputum production. |
Cardiovascular and exercise | Dysrhythmia that might pose a risk during exercise or training. Congestive heart failure within 6 mo and LVEF < 45%. Resting bradycardia (< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, or sustained SVT. Myocardial infarction within 6 mo and LVEF < 45%. Clinical suspicion or proven history of pulmonary hypertension. History of exercise-related syncope. Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer. |
Surgical | Prior lung transplant, lung volume reduction surgery, median sternotomy, bullectomy or lobectomy. |
General medical | Unplanned weight loss of >10% usual weight in 90 days prior to enrollment or total body weight < 70% of ideal body weight. Alpha-1 antitrypsin deficiency. Fever, elevated white cell count, or other evidence of active infection. Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period. Any disease or condition that interferes with completion of initial or follow-up assessments. Patient is currently enrolled in another clinical trial or has been previously enrolled in the VENT Trial for which protocol required follow up is not complete. |
Abbreviations: HRCT = high resolution chest computed tomography, FEV1 = forced expiratory volume in one second, DLco = diffusion of the lung for carbon monoxide, LVEF = left ventricular ejection fraction, PVC = premature ventricular contractions, SVT = supraventricular tachycardia.